Post : Executive RA

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VACANCY AT NANO THERAPEUTICS PVT LTDAS EXECUTIVE REGULATORY AFFAIRS

At Nano, they are working to help people live not just longer, but better, in the area we serve.
They, design, develop, Manufacture & Supply Vascular Stents, Stent Systems & Support Devices. They are actively pursuing development of Interventional Bronchology and ENT medical devices.

Post : Executive RA

As an Executive – Regulatory Affairs with this fast growing, Class III medical device company, you will be responsible to provide support to your superior for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advice on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues.

Job Description
• Collect and coordinate information and prepare regulatory documentation for submission to
regulatory agencies or to commercial partners, advice on the submission strategy
• Maintain up-to-date knowledge on domestic and international regulatory requirements,
regulations, standards, and guidance and ensure effective communication to the project teams
and management.
• Maintain regulatory files/database and chronologies in good order
• Maintain system for tracking changes in documents submitted to agencies or partners
• Prepare documents change orders, technical documents, test protocols and reports, risk
management documents, and other documents as a key member of the project teams
• Prepare labeling and promotional materials to ensure compliance with international
requirements
• Prepare regulatory submissions, including not limited to: Technical File, Design Dossier, PMS,
Clinical Follow ups, Manufacturing and Marketing Applications
• Participate and support external audits (FDA, CE Notified Body, ISO 9001, ISO 13485, Third party Audit) and internal audits.
• Review advertising and marketing material for appropriateness and compliance to regulatory
requirements and laws.
• Timely compile materials for license renewals, updates and registrations
• Provide the regulatory reviews of customer complaints
• Responsible for timely registration of the facility
• Maintain current knowledge of FDA and international regulation, guidance and standards
applicable to company products
• Actively provide support to superior in evaluation of regulatory compliance of document /
product / process /test methods changes
• Provide support to superior to represent Regulatory Affairs on R&D product development
project teams to ensure all regulatory requirements are met throughout the development
process.
• Participate in research of regulatory issues and dissemination regulatory information to
Production, QA, QC and R&D departments and senior management as required.

Specific Skills, Knowledge & Behaviors:
(to perform the job successfully, an individual should demonstrate the following competencies):
• Strong interpersonal skills including ability to interact with high degree of diplomacy
• Knowledge of EU and international medical device regulatory requirement
• Ability to work effectively in a team environment
• Ability to interface with all levels of management and regulatory body representatives.
• Excellent written and oral communication skills
• Ability to work in a fast-paced, technically challenging environment where drive is critical to
success
• Maintain corporate confidentiality at all times.

Area:Medical Devices

Additional Information
Qualification :Bachelor’s/Master’s degree in a scientific discipline or equivalent is required.
Location :Plot No D54/2, Hojiwala Industrial Estate, Road No. 23, Near Gate No. 3, Sachin Palsana Highway, Surat, Gujarat 394230
Industry Type : Pharma

Interested candidates can mail their updated resume to undersigned.

Contact Details:
MansiShukla
Placement Manager (IGMPI)
E-mail: corporate.resources@igmpi.org
Telephone: +91 8448775080; 0120-2427175; 0120-4375280

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